Resurgence in pharma recalls expected

June 9, 2020

There were just 12 new recalls in pharma in May — the lowest number of recalls in the industry since February 2015. But several factors are expected to contribute to a sharp rise in recalls this year.

After the spread of the coronavirus was declared a pandemic, the FDA put a temporary ban on overseas inspections of pharma facilities, which contributed to a lower number of recalls in Q1 of this year, according to a recent report by Stericycle. Although the slowdown of facility inspections has contributed to a decrease in pharma recalls, the FDA has still been calling out pharma companies for cGMP deviations.

“By and large, the FDA is continuing to post warning letters on its website and request voluntary recalls. Despite the publicized regulatory discretion, that agency hasn’t fully backed off product safety,” says Chris Harvey, director of Recalls at Stericycle Expert Solutions.

Now, the FDA is working with the CDC to create a plan for a phased approach to re-starting overseas facility inspections. Naturally, as soon as the FDA can get back into the swing of on-site inspections, the agency is likely to find more deviations which will thus, trigger more recalls. But Stericycle points to other factors that could drive an increase in health care-related recalls this year: 

  • The emphasis on quickly ramping up production of certain medicines to fight the coronavirus, which could put quality at risk.
  • The entry of non-health care companies into the medical device manufacturing field (such as Ford Motor Company), who are not as familiar with the FDA’s complex regulatory environment.  

Although some companies have been shifting to virtual audits of overseas suppliers instead of traveling to facilities — and some are requesting that the FDA do the same — Harvey says that he doesn’t see that trend taking the place of on-site inspections in the long-term.

“What I’ve heard from pharma manufacturers is that a lot of times when they audit facilities, they want to be on-site,” he says.

Now, Harvey says it’s time for pharma companies to get ready for the FDA’s imminent return. 

“The No. 1 thing right now is that manufacturers stay diligent with quality,” he says.